FDA recall D1834-2015

Product

Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by Apotex Research Private Limited, Bangalore, Karnataka 560 099, India; Manufactured for: Apotex Corp., Weston, FL 33326. NDC 60505-2742-5.

Reason for recall

Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2015-07-21

Report date

2015-10-07

Termination date

2017-02-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Toronto, Ontario, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D1834-2015